Phase III Study to Demonstrate the non inferiority of PLURAIR® branded nasal topical Fluticasone Propionate (FP) in relation to the FLIXONASE® brand reference drug in the control of nasal symptoms related to perennial allergic rhinitis.
This study was conducted to demonstrate the non inferiority of the topical nasal fluticasone propionate of the brand Plurair® in relation to the reference drug Flixonase® in the control of symptoms related to perennial allergic rhinitis. Allergic rhinitis is one of the most common forms of non-infectious rhinitis, characterized mainly by symptoms such as sneezing, runny nose and nasal congestion. Depending on the time of exposure to allergens and the duration of symptoms, allergic rhinitis is classified as perennial (OKUBO, 2009). Studies for the assessment of perennial allergic rhinitis through symptom analysis used diaries provided to the participants, so that they could describe their symptoms, starting in the screening phase and ending at the end of treatment. In the present study, participants recorded, in the diary, the severity of their rhinitis symptoms (obstruction, runny nose, nasal itching and sneezing) and also associated eye symptoms (watery eyes, itchy eyes and redness) using a four-point scale (0-absent, 1-mild, 2-moderate and 3-severe). For the purpose of analyzing the primary parameter, the total daily reflective nasal symptoms (NRT) was obtained by averaging the total morning and evening scores for each day (\[morning NRT + night NRT\] / 2) of the individual nasal symptoms - obstruction, itching, runny nose and sneezing - assessed reflexively in the last 12 hours. This study in its design and analysis of efficacy and safety followed the guidelines of regulatory agencies in the United States of America (FDA, 2000) and Canada (CANADA HEALTH, 2011). Fluticasone propionate is a potent intranasal corticosteroid with negligible bioavailability, effective in the treatment of nasal symptoms of allergic rhinitis. The onset of the therapeutic effect of fluticasone propionate occurs within 12 hours when 200 μg of the medication is administered once a day (RATNER, 2008). Following guidelines for the use of fluticasone propionate and guidelines for the assessment of symptoms of perennial allergic rhinitis, the objective of the present clinical study was to evaluate the efficacy and safety of two formulations of fluticasone propionate as a single agent in the treatment of perennial allergic rhinitis through relief of nasal symptoms assessed by recording in the participants' symptom diary. This study was conducted in accordance with the proposal for the treatment of perennial allergic rhinitis, with local clinical research regulations, with the International Harmonization Conference (ICH) Good Clinical Practices and with the principles of the Declaration Helsinki and their respective revisions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
566
Variation of the mean of total reflective nasal symptoms (TSNr)
Patients should be instructed to classify and note the severity of nasal symptoms (itching, sneezing, obstruction and coryza) using the "Research participant's diary", the reflexive way in the last 12 hours, with an assessment in the morning and another at night (twice a day, regardless of specified times), with a 4-point scale below: 0: ABSENT - this symptom is not present. 1. Mild - this symptom is present, but does not bother. 2. MODERATE - this symptom is present and is substantially received, but it does not get in the way of your daily activities / sleep quality. 3. SEVERE - this symptom is present, enters substantially and gets in the way of your daily activities / sleep quality.
Time frame: daily records over the 4 weeks of treatment in relation to their baseline value.
Variation of total instant nasal symptoms (TSNi)
Patients should be instructed to classify and note the severity of nasal symptoms (itching, sneezing, obstruction and runny nose) individually in the "Research participant's diary", instantly in the morning (upon waking up and before using the medication, without consideration) specific times), according to the 4-point scale below: 0: ABSENT - this symptom is not present. 1. Mild - this symptom is present, but does not bother. 2. MODERATE - this symptom is present and substantially bothers, but it does not get in the way of your daily activities / sleep quality. 3. SEVERE - this symptom is present, it substantially bothers and gets in the way of your daily activities / sleep quality.
Time frame: over the 4 weeks of treatment
Variation of each nasal symptom
Patients should be instructed to classify and note the severity of nasal symptoms (itching, sneezing, obstruction and runny nose) individually in the "Research participant's diary", in a reflexive way in the last 12 hours, with an assessment in the morning and another in the evening (twice a day, regardless of specific times), according to the 4-point scale below: 0: ABSENT - this symptom is not present. 1. Mild - this symptom is present, but does not bother. 2. MODERATE - this symptom is present and substantially bothers, but it does not get in the way of your daily activities / sleep quality. 3. SEVERE - this symptom is present, it substantially bothers and gets in the way of your daily activities / sleep quality.
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Time frame: over the 4 weeks of treatment
Variation of total ocular symptoms and in each specific ocular symptom
Patients should be instructed to classify and note the severity of eye symptoms individually - tearing, itching and redness - in the "Research participant's diary", in a reflexive way in the last 12 hours, with an assessment in the morning and another at night (two times a day, without considering specific times), according to the 4-point scale below: 0: ABSENT - this symptom is not present. 1. Mild - this symptom is present, but does not bother. 2. MODERATE - this symptom is present and substantially bothers, but it does not get in the way of your daily activities / sleep quality. 3. SEVERE - this symptom is present, it substantially bothers and gets in the way of your daily activities / sleep quality.
Time frame: over the 4 weeks of treatment
Patient's overall impression of treatment efficacy at the end of the study
At the end of treatment (4 weeks), each patient should assess their overall satisfaction with the treatment's effectiveness, according to the following scale: 0 = complete improvement of symptoms 1. = moderate symptom improvement 2. = slight improvement of symptoms 3. = no change in symptoms 4. = slight worsening of symptoms 5. = moderate worsening of symptoms 6. = severe worsening of symptoms
Time frame: over the 4 weeks of treatment
Researcher's general impression at the end of the study
At the end of the treatment (4 weeks), the researcher will answer about his general impression regarding the effectiveness of the treatment, according to the following scale: 0 = complete improvement of symptoms 1. = moderate symptom improvement 2. = slight improvement of symptoms 3. = no change in symptoms 4. = slight worsening of symptoms 5. = moderate worsening of symptoms 6. = severe worsening of symptoms
Time frame: over the 4 weeks of treatment